Prothia USA, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Prothia USA, Inc.” (first 1982, latest 1983), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 59 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BXN | Stimulator, Nerve, Battery-Powered | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GFD | Dermatome | 1 | 1 |
| GZX | Instrument, Microsurgical | 1 | 1 |
Review panels
Most recent Prothia USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K831071 | UNIVERSAL INSTRU. SET FOR NEUROVASCULAR | GZX | 1983-06-08 | 65 |
| K830993 | AMPLIGREFFE | GFD | 1983-05-03 | 35 |
| K823581 | ELPHA 500 | GCJ | 1983-03-24 | 108 |
| K830058 | MYOGRAPH 2000 | BXN | 1983-03-07 | 59 |
| K823583 | MYOTEST NERVE STIMULATOR | BXN | 1982-12-30 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Prothia USA, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Prothia USA, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Prothia USA, Inc.” (first 1982, latest 1983), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Prothia USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Prothia USA, Inc. is 59 days.
Which FDA product codes appear under Prothia USA, Inc.?
The most frequent FDA product codes under this applicant name are BXN (Stimulator, Nerve, Battery-Powered, 2); GCJ (Laparoscope, General & Plastic Surgery, 1); GFD (Dermatome, 1).
Next steps
- See all 5 Prothia USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BXN, Prothia USA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.